The following is a summary of “Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial,” published in the June 2023 issue of Oncology by Krauss, et al.
For a study, researchers sought to assess the effectiveness of an artificial intelligence (AI)/machine learning (ML) decision support tool in predicting the need for palliative care services among hospitalized patients.
A pragmatic, cluster-randomized, stepped-wedge clinical trial was conducted over 15 months involving 12 nursing units at two hospitals from August 19, 2019, to November 17, 2020. The study randomly assigned 1,492 patients with stage T2b-T2c, Gleason score 7, or prostate-specific antigen (PSA) value >10 and ≤20 ng/mL to receive either dose-escalated radiotherapy (RT) alone (arm 1) or dose-escalated RT with short-term androgen deprivation (STAD) therapy (arm 2). STAD therapy consisted of 6 months of luteinizing hormone–releasing hormone agonist/antagonist therapy plus an antiandrogen. The primary outcome measure was overall survival (OS), and secondary outcomes included prostate cancer–specific mortality (PCSM), non-PCSM, distant metastases (DMs), PSA failure, and rates of salvage therapy.
The median follow-up duration was 6.3 years. Among the 1,492 patients, 119 deaths occurred in arm 1, and 100 deaths occurred in arm 2. The 5-year OS estimates were 90% in arm 1 and 91% in arm 2 (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11; P = .22). STAD therapy resulted in a significant reduction in PSA failure (HR, 0.52; P < .001), DM (HR, 0.25; P < .001), PCSM (HR, 0.10; P = .007), and use of salvage therapy (HR, 0.62; P = .025). There was no significant difference in other-cause deaths (P = .56). Acute grade ≥3 adverse events (AEs) occurred in 2% of patients in arm 1 and 12% in arm 2 (P < .001). The cumulative incidence of late grade ≥3 AEs was 14% in arm 1 and 15% in arm 2 (P = .29).
Integrating an AI/ML decision support tool into palliative care practice showed an increased rate of palliative care consultation among hospitalized patients and reduced hospitalizations. However, short-term androgen deprivation (STAD) therapy did not improve overall survival rates in men with intermediate-risk prostate cancer (IRPC) treated with dose-escalated radiotherapy (RT). The benefits in reducing PSA failure, distant metastases, and prostate cancer-specific mortality should be carefully considered about the risk of adverse events and the impact on quality of life.